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Amgen Says FDA Completes Review Of SNDA Seeking Full Approval For LUMAKRAS
(RTTNews) - Amgen, Inc. (AMGN) announced Tuesday that the U.S. Food and Drug Administration (FDA) has completed its review of the company's supplemental New Drug Application seeking full approval of LUMAKRAS (sotorasib).
The review, which resulted in a Complete Response Letter, was based on the CodeBreaK 200 trial results for the treatment of adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC).
The FDA also issued a new postmarketing requirement (PMR) for an additional confirmatory study to support full approval that will be completed no later than February 2028.
In addition, the FDA concluded that the dose comparison PMR issued at the time of LUMAKRAS accelerated approval, to compare the safety and efficacy of LUMAKRAS 960 mg daily dose versus a lower daily dose, has been fulfilled.
The company said LUMAKRAS at 960 mg once-daily will remain the dose for patients with KRAS G12C-mutated NSCLC under accelerated approval.
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Amgen's Bkemv Approved As First Interchangeable Biosimilar To Soliris
The U.S. Food and Drug Administration has approved Amgen Inc.'s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab), developed by British drug major AstraZeneca's Rare Disease unit Alexion Pharmaceuticals, to treat certain rare diseases. Soliris is a medicine used to treat adults and children with paroxysmal nocturnal haemoglobinuria or PNH...
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438天前
Amgen To Open Manufacturing Site In Central Ohio; To Offer 400 Full-time Jobs
Amgen, Inc. (AMGN) announced Monday the opening of its manufacturing site in Central Ohio, the newest in its global operations network and the most advanced facility to date.
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532天前
Amgen, Horizon Therapeutics Reach Settlement On FTC Lawsuit; Seeks To Close Acquisition In Q4
Amgen (AMGN) and Horizon Therapeutics plc (HZNP) announced Friday the entry into a consent order agreement with the Federal Trade Commission (FTC) that resolves the pending FTC administrative lawsuit. This clears the path to take the final steps to close Amgen's $27.8 billion acquisition of Horizon.
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710天前
Amgen Announces Positive Top-line Results From Phase 3 DAHLIA Study Of ABP 959
Amgen, Inc. (AMGN) announced Tuesday positive top-line results from the DAHLIA study, a randomized, double-blind, active-controlled, two-period crossover Phase 3 study evaluating the efficacy and safety of ABP 959, a biosimilar candidate to SOLIRIS (eculizumab), compared with SOLIRIS in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
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1084天前
Singapore Bourse May Give Up Support At 4,200 Points
The Singapore stock market has finished lower in two straight sessions, slipping more than 25 points or 0.6 percent along the way. The Straits Times Index now sits just above the 4,230-point plateau and it may extend its losses on Tuesday.
The global forecast for the Asian markets is soft ahead of key U.S. inflation data. The European markets were mixed and the U.S. bourses were down and the Asian markets also figure to track into the red.
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24分鐘前
Rally May Stall For Malaysia Stock Market
The Malaysia stock market has moved higher in five straight sessions, collecting more than 35 points or 2.4 percent along the way. The Kuala Lumpur Composite Index now sits just above the 1,560-point plateau although it's due for consolidation on Tuesday.
The global forecast for the Asian markets is soft ahead of key U.S. inflation data. The European markets were mixed and the U.S. bourses were down and the Asian markets also figure to track into the red.
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54分鐘前
Win Streak May End For Japan Stock Market
Ahead of Monday's holiday for Mountain Day, the Japan stock market had moved higher in four consecutive sessions, advancing more than 1,580 points or 3.8 percent along the way. The Nikkei 225 now sits just above the 41,820-point plateau although investors are likely to lock in gains on Tuesday.
The global forecast for the Asian markets is soft ahead of key U.S. inflation data. The European markets were mixed and the U.S. bourses were down and the Asian markets also figure to track into the red.
The Nikkei finished sharply higher on Friday with gains cross the board, especially among the finance, automobile and technology sectors.
For the day, the index surged 761.38 points or 1.85 percent to finish at 41,820.48 after trading between 41,248.05 and 42,033.92.
Among the actives, Nissan Motor accelerated 2.75 percent, while Mazda Motor spiked 4.91 percent, Toyota Motor jumped 3.47 percent, Honda Motor rallied 3.95 percent, Softbank Group skyrocketed 10.39 percent, Mitsubishi UFJ Financial collected 0.64 percent, Mizuho Financial advanced 1.02 percent, Sumitomo Mitsui Financial added 0.71 percent, Mitsubishi Electric fell 0.28 percent, Sony Group soared 3.50 percent, Panasonic Holdings climbed 1.16 percent and Hitachi rose 0.50 percent.
The lead from Wall Street is negative as the major averages opened mixed on Monday, rallied midday but then slumped in the afternoon and finished under water.
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1小時9分鐘前
Continued Consolidation Called For South Korea Shares
The South Korea stock market has finished lower in back-to-back sessions, sinking more than 20 points or 0.6 percent along the way. The KOSPI now sits just above the 3,200-point plateau and it may take further damage again on Tuesday.
The global forecast for the Asian markets is soft ahead of key U.S. inflation data. The European markets were mixed and the U.S. bourses were down and the Asian markets also figure to track into the red.
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1小時24分鐘前
